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Blood collection devices containing contact pathway inhibition additives

a technology of contact pathway and additives, which is applied in the field of blood collection devices containing contact pathway inhibition additives, can solve the problems of cti-inclusion blood collection tubes that cannot be sterilized, amplification of accumulated factor xiia via involvement of kallikrein-kinin, and fibrin clot formation active thrombin generation and fibrin clot formation, etc., to achieve robust effect, prolong clotting time, and stabilize thrombin generation

Inactive Publication Date: 2014-08-07
BECTON DICKINSON & CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about a device for collecting blood or a composition containing a component of blood. The device has an interior wall with an additive or combination of additives that inhibits the contact coagulation pathway activation, which prevents the formation of blood clots. One of the additives blocks the activity of Factor XIa, which is involved in the contact coagulation pathway. The use of these additives with sodium citrate evacuated blood collection tubes significantly extends the time it takes for the blood to clot. The device is sterile and evacuated, with a closure that can be pierced by a needle for supplying blood to the reservoir.

Problems solved by technology

This cascade eventually results in active thrombin generation and fibrin clot formation.
However, several problems exist with using CTI to suppress thrombin generation via the contact coagulation pathway.
One such problem is the amplification of accumulated factor XIIa via involvement of the kallikrein-kinin system.
Another problem is that blood collection tubes that include CTI cannot be sterilized and thus cannot be used in conjunction with certain clinical applications.
Generation of thrombin through the contact pathway can skew TEG results depending on the vessel or container used in the test.

Method used

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  • Blood collection devices containing contact pathway inhibition additives
  • Blood collection devices containing contact pathway inhibition additives
  • Blood collection devices containing contact pathway inhibition additives

Examples

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example 1

[0059]Thrombelastography (TEG) is useful in testing coagulation efficiency of whole blood (WB) and has found important applications during surgery and anesthesiology. The CAT assay performed in plasma is used to investigate patients with hypo- or hypercoagulopathies. These assays are highly sensitive relative to traditional coagulation tests and vulnerable to contact activation where accumulated factor XIIa in citrated specimens can markedly augment down-stream thrombin generation (TG). Accordingly, the effect of blood collection tubes comprised of different polymeric containment materials and the select use of targeted intrinsic pathway inhibitors on select outputs of the TEG and CAT assays are examined.

[0060]Citrated human WB is transferred from a blood collection bag into coated (siliconized) glass or plastic blood collection tubes, or uncoated glass, polypropylene (PP), polystyrene (PS), or polyethylene terephthalate (PET) conical bottom tubes, either alone or in the presence of...

example 2

[0063]As shown in FIG. 4(A) various concentrations of aprotinin were used in tests to determine the impact on whole blood clotting time using TEG. Citrated blood samples incubated in uncoated glass tubes were subjected to different concentrations of aprotinin measured in KIU (kallikrein inhibiting units) / mL and compared to blood samples without aprotinin but contained in siliconized glass tubes or plastic tubes. Results from this assay show that concentrations of aprotinin of 1000 KIU / mL and higher mitigate the contact coagulation pathway in uncoated glass tubes to a level equivalent to mitigation of the contact coagulation pathway in blood samples stored in siliconized glass tubes or plastic tubes.

[0064]CAT assay of samples with different amounts of aprotinin show that as aprotinin amounts is increased per sample, thrombin generation is decreased and delayed, even in the presence of CaCl2 and TF. This result is shown in FIG. 4(B) for siliconized glass (top panel) and plastic tubes ...

example 3

[0065]The aPTT assay was used to show that aprotinin mitigated the contact coagulation pathway in a manner equivalent to inhibition by CTI and anti-Factor XI antibody. As shown in FIG. 6, increased amounts of aprotinin prolong the time to generate thrombin that or equivalent to or greater than the time to generate thrombin in the presence of CTI and anti-Factor XI antibody. FIG. 6 (lower panels) show that using the identical samples in tests that monitor the TF coagulation pathway exclusively, the thrombin generation is unaffected by aprotinin, CTI or anti-Factor XI antibody. This verifies that aprotinin exclusively suppresses thrombin formation through the contact coagulation pathway but not through the TF pathway.

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Abstract

Disclosed are devices for collecting blood that contain an anti-coagulant and an additive that delays clotting by inhibiting the contact pathway for thrombin generation. The additive is a coagulation contact pathway inhibitor additive that is at least one of a Factor XI inhibitor, a Factor XII inhibitor, a kallikrein inhibitor and combinations thereof, each in an amount effective to mediate or suppress the contact pathway for thrombin generation. Methods of making and using the devices, and kits containing the devices, are also provided.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 61 / 759,742 filed Feb. 1, 2013, the disclosure of which is hereby incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]It is well known that blood and plasma will clot when exposed to conditions that activate the coagulation pathway that ultimately forms fibrin. Fibrin itself is formed through the activity of thrombin and is therefore a consequence of thrombin generation. Thrombin generation is initiated by two enzymatic cascades involving several different factors (peptidases) that eventually converge in a common pathway which produces active thrombin. The two cascades that result in thrombin formation are the tissue factor (TF) coagulation pathway (also known as the extrinsic pathway) and the contact coagulation pathways (also known as the intrinsic pathway). The TF pathway is initiated through the exposure of circulating factor...

Claims

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Application Information

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IPC IPC(8): A01N1/02
CPCA01N1/0226A61J1/06A61J1/1406A01N1/0263G01N33/86B01L3/50215B01L2300/042B01L2300/044
Inventor MOSKOWITZ, KEITH A.SINQUETT, FRANK L.
Owner BECTON DICKINSON & CO
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